RecruitingPhase 2NCT06997081

ERd Combination Treatment in Newly Diagnosed Multiple Myeloma

Elranatamab, Lenalidomide, Dexamethasone in Newly Diagnosed Multiple Myeloma, a Clinical and Correlative Phase 2 Study

Sponsor

University of Miami

Enrollment

104 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The purpose of this study is to determine the effects that Elranatamab in combination with Lenalidomide and Dexamethasone has on participants that have been newly diagnosed with Multiple Myeloma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — elranatamab (a bispecific antibody), lenalidomide, and dexamethasone (ERd) — in people who have just been diagnosed with multiple myeloma (a blood cancer of plasma cells) and have not yet started treatment. The goal is to achieve deep, long-lasting responses including MRD-negativity (no detectable cancer cells). **You may be eligible if...** - You are 18 or older with a newly diagnosed confirmed multiple myeloma - You have measurable disease in blood, urine, or bone marrow - Your blood counts and organ function are adequate - You are willing to enroll in the lenalidomide REMS safety program (required by regulations) **You may NOT be eligible if...** - You have received more than one cycle of prior treatment for multiple myeloma - You have active cancer in the brain or spinal fluid - You have had major surgery in the past 2 weeks - You have active HIV, hepatitis B or C, severe heart disease, uncontrolled asthma, or active serious infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenalidomide

Participants will receive 25mg of Lenalidomide orally on Days 2-21 of Cycle 1, then 25 mg by mouth on Days 1-21 of the remaining cycles.

DRUGDexamethasone

Participants will receive 20mg of Dexamethasone orally on Days 1, 3, 8, and 15 of Cycle 1, then 4mg orally on Days 1 and 15 of Cycles 4-6.

DRUGElranatamab

Participants will receive 12mg Elranatamab subcutaneous (SC) on Cycle 1; 32mg subcutaneous (SC) on Cycle 1 Day 3; 76mg subcutaneous (SC) on Cycle 1 Day 8 and Day 15. Then, participants will receive 76mg subcutaneous (SC) on Days 1 and 15 of Cycles 2-6. Lastly, participants will receive Elranatamab subcutaneous (SC) on Day 1 of the remaining cycles.